PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01856166
First received: April 29, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.

To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.


Condition Intervention
Pregnancy
Device: Release analgesia by CADD SMITHS PCEA pump
Device: Release analgesia by CADD SMITHS PIEB pump
Drug: Levobupivacaine
Drug: Sufentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Programmed Intermittent Epidural Bolus Coupled With PCEA (PIEB-PCEA) Versus Continuous Epidural Infusion Coupled With PCEA (CEI-PCEA) for Labor Analgesia in Nulliparous: Effects on Labor Outcomes

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Occurence of a specific clinical criteria which can lead to a complication of the delivery [ Time Frame: Up to 10 hours ] [ Designated as safety issue: No ]

    Specific clinical criteria are:

    • Type of posterior engagement
    • Type of posterior extrication
    • Duration of waiting at complete dilatation > 3 hours
    • Duration of expulsive efforts > 40 minutes
    • Foetal bradycardia < 100 BPM during 1 minute at least


Secondary Outcome Measures:
  • Instrumental delivery rate [ Time Frame: up to 10 hours ] [ Designated as safety issue: No ]
  • Pain during the end of labor [ Time Frame: up to 10 hours ] [ Designated as safety issue: No ]
  • Efficacity of epidural analgesia [ Time Frame: up to 10 hours ] [ Designated as safety issue: No ]
  • Efficacity of epidural analgesia [ Time Frame: up to 10 hours ] [ Designated as safety issue: No ]
    Efficacity of epidural analgesia is defined by a EVN score < 3 at several times of delivery.

  • Presence of motor block [ Time Frame: Up to 10 hours ] [ Designated as safety issue: No ]
    Presence of motor block is estimated with Bromage and Straigh Raising leg scales.


Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CEI-PCEA
Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia
Device: Release analgesia by CADD SMITHS PCEA pump
Analgesia will be release by continuous manner with an automatic pump
Drug: Levobupivacaine Drug: Sufentanil
Experimental: PIEB-PCEA
Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia
Device: Release analgesia by CADD SMITHS PIEB pump
Analgesia will be release by bolus with an automatic pump
Drug: Levobupivacaine Drug: Sufentanil

Detailed Description:

Patients will be informed during the anaesthetic consultation and recruited at the beginning of the labor if they comply with inclusion criteria. Habitual proceedings of the placing and induction of epidural analgesia (Local Anaesthetics (AL): Levobupivacaine 0.100% 15mL Sufentanil 10µg). Patients who will not obtain at 30min a pain score < 1/10 will be excluded (epidural analgesia not functional). The upkeep of analgesia will be provided by an automatic pump and randomized in: classic pump and new pump. The mixture used will be the same in the 2 groups: Levobupivacaine 0.0100% + Sufentanil 0.5µg/mL. The classic pump administers AL with a continuous output (8mL/h)even though the new pump administers AL in bolus (8mL every hour; beginning 1h after the induction). The classic pump is a pump CADD SMITHS PCEA (Patient Controlled Epidural Analgesia) with the programming: continuous output 8mL/h; Additional bolus if necessary: 8mL; Maximal dose by hour: 24mL.

The new pump is a pump CADD SMITHS called PIEB (Programmed Intermittent Epidural Bolus) with the programming: intermittent bolus 8mL every hour; Additional bolus if necessary: 8mL; Ban period during 10min between patient bolus and automatic bolus; Maximal dose by hour: 24mL.

In case of the pain reappears and which is not calmed with 2 successive patient bolus, the anaesthetist will be called for the evaluation and administration of a doctor bolus if necessary (Levobupivacaine 0.125% 5mL associated with 50µg of Clonidine).

Collected data will be demographic data, data about the obstetrical labor proceedings, data about pain, motor block, maternal satisfaction, total quantity of administered analgesia, number of patient and doctor bolus wich are asked and administered and neonatal data.

Endpoints will be collected by a doctor in blind of the type of pump (the 2 pumps are the same extern aspect, only the intern programming is different).

In case of caesarean during the labor, patient will be excluded of the study. When a decision of extraction will be taken, patient will receive a bolus of AL according to the anaesthetist decision but not accounted for the dose calculation.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nulliparous patient with a spontaneous labor at full term, from a normal pregnancy, carrier a singleton in cephalic position, with a distension <4cm and eligible for an epidural analgesia
  • Patient has signed informed consent
  • Patient affiliated or beneficiary of a social medical insurance
  • Patient aged between 18 and 44 years old

Exclusion Criteria:

  • Morphinic administration before the care
  • Anomaly of fetal cardiac rate
  • Fetal or maternal anomalies wich don't allow to evaluate motor block
  • Known uterine malformation
  • Contraindications for thrusts for pregnancy
  • Patient protected by law
  • Patient under guardianship
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856166

Contacts
Contact: Estelle MORAU, MD 0665849512 e-morau@chu-montpellier.fr

Locations
France
Hôpital Mère Enfant Not yet recruiting
Bron, France, 69500
Contact: Dominique CHASSARD, MD PhD    0472129763    dominique.chassard@chu-lyon.fr   
Principal Investigator: Dominique CHASSARD, PU-PH         
CHU d'Estaing Not yet recruiting
Clermont Ferrand, France, 63003
Contact: Martine BONNIN, MD    0472129763    mbonnin@chu-clermontferrand.fr   
Principal Investigator: Martine BONNIN, MD         
Sub-Investigator: Brigitte STORME, MD         
CHU Bicêtre Not yet recruiting
Le Kremlin Bicêtre, France, 94275
Contact: Dan BENHAMOU, MD-PHD       dan.benhamou@bct.aphp.fr   
Principal Investigator: Dan BENHAMOU, MD PhD         
CHU of Montpellier Not yet recruiting
Montpellier, France, 34000
Contact: Estelle MORAU, PhD    0665849512    e-morau@chu-montpellier.fr   
Contact: Claire CHAUVETON    0467330924    c-chauveton@chu-montpellier.fr   
Principal Investigator: MORAU Estelle, MD         
Sub-Investigator: Aurélien BONNAL, MD         
Sub-Investigator: Pascal COLSON, MD PhD         
Sub-Investigator: Jacques DUBOURDIEU, MD         
Sub-Investigator: Charles LEGOUX, MD         
Sub-Investigator: Marie BARBIER, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Estelle MORAU, PhD CHU Montpellier - Department of gynaecology and obstetric
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01856166     History of Changes
Other Study ID Numbers: 9147
Study First Received: April 29, 2013
Last Updated: May 16, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Montpellier:
Nulliparous
Singleton
delivery
pregnancy

Additional relevant MeSH terms:
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014